FDA recall D-0855-2021

Monarch PCM, LLC · Class II · drug

Product

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

Reason for recall

Finished product specification did not meet USP specifications.

Distribution

Key facts

Status: Terminated
Initiation date: 2021-09-23
Report date: 2021-10-06
Termination date: 2023-06-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2021